Overview
Join ACI at the 44th Annual FDA Boot Camp, where life sciences counsel and industry executives get a clear, grounded framework for how FDA is operating right now, so you can navigate approvals, labeling and promotion, quality and safety expectations, and emerging technologies without overreacting to headlines or underestimating risk.
A McDermott attorney will speak at the following session:
Clarifying the Clinical Trial Process for Drugs and Biologics
March 25, 2026
1:15 – 2:15 pm (EST)
Speaker: Marissa Hill Daley
Enrollment stalls, diversity misalignment, and decentralized-trial hiccups can derail timelines even when the science is sound. This session turns statutory diversity and DCT realities into documentable plans that reviewers trust and sites can deliver.
Topics of discussion include:
- Drafting diversity action plans and requesting waivers with defensible rationales
- Selecting sites and networks to achieve representation benchmarks
- Maintaining data integrity and monitoring decentralized and hybrid execution